Toxicological Risk Assessment (ISO 10993-17): Biological Safety Evaluation
Toxicological Risk Assessment (TRA) is a critical step in the biological evaluation of medical devices, serving as the bridge between chemical analysis and clinical safety. Once chemical substances are identified through Extractables and Leachables (E&L) studies, a TRA determines if the levels of these substances pose a risk to the patient under clinical use conditions.
At EBI, we provide comprehensive toxicological reports that satisfy Notified Bodies and regulatory authorities by providing clear, data-driven conclusions on patient safety.
Why is Toxicological Evaluation Essential for Your Device?
Under the Medical Device Regulation (MDR), raw analytical data from a lab is no longer enough. Auditors require a formal evaluation of the potential hazards associated with every identified chemical. A professionally conducted TRA can:
- Reduce Animal Testing: In many cases, a robust TRA combined with chemical data can justify the waiver of certain in vivo biological tests.
- Identify Potential Hazards: Detect carcinogens, mutagens, or reproductive toxins (CMR substances) early in the development cycle.
- Calculate Exposure Limits: Establish scientifically sound safety thresholds for your specific patient population.
Methodology and Risk Assessment Process
Our toxicological team follows a structured, tiered approach to ensure every compound is accounted for:
- Hazard Identification: We perform extensive literature screening across global toxicological databases to identify known adverse effects of each substance.
- Dose-Response Assessment: Determination of the Tolerable Intake (TI) or Tolerable Exposure (TE) levels based on established toxicological points of departure (POD).
- Exposure Assessment: We calculate the Estimated Exposure Dose (EED) based on the device’s clinical use, contact duration, and patient body weight.
- Risk Characterization: Calculation of the Margin of Safety (MOS). A device is generally considered safe if the MOS is greater than 1.
- In Silico Modeling (QSAR): For substances with limited toxicological data, we utilize advanced computational modeling to predict toxicity based on chemical structure.
Sample Requirements and Turnaround Time
Since a Toxicological Risk Assessment is a desk-based expert evaluation, physical samples of the device are not required for this phase.
- Required Documentation: Complete reports from ISO 10993-18 chemical characterization (GC-MS, LC-MS, ICP-MS data), device intended use, and material composition.
- Standard Turnaround Time: 4 weeks.
- Deliverable: A comprehensive Toxicological Risk Assessment report signed by a qualified toxicologist.
Compliance with ISO 10993-17 and MDR
Our assessments are performed in full compliance with the latest versions of:
- ISO 10993-17: Establishment of allowable limits for leachable substances.
- ISO 10993-1: Evaluation and testing within a risk management process.
- MDR 2017/745: Addressing requirements for substances of concern.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ: Toxicological Risk Assessment
What is the „Margin of Safety” (MOS)?
The MOS is the ratio between the safe dose (Tolerable Exposure) and the actual dose the patient receives (Estimated Exposure). An MOS > 1 indicates that the exposure is below the level expected to cause adverse effects.
Can I perform a TRA without E&L testing?
Generally, no. A TRA requires quantitative data on what chemicals are leaching from the device. Without ISO 10993-18 data, the toxicologist has no basis to perform the risk calculation.
What happens if a compound has no available toxicity data?
In such cases, we use In Silico (QSAR) modeling to predict toxicity or apply the Threshold of Toxicological Concern (TTC) approach, a conservative screening tool accepted by regulatory bodies.
What is the "Margin of Safety" (MOS)?
The MOS is the ratio between the safe dose (Tolerable Exposure) and the actual dose the patient receives (Estimated Exposure). An MOS > 1 indicates that the exposure is below the level expected to cause adverse effects.
Can I perform a TRA without E&L testing?
Generally, no. A TRA requires quantitative data on what chemicals are leaching from the device. Without ISO 10993-18 data, the toxicologist has no basis to perform the risk calculation.
What happens if a compound has no available toxicity data?
In such cases, we use In Silico (QSAR) modeling to predict toxicity or apply the Threshold of Toxicological Concern (TTC) approach, a conservative screening tool accepted by regulatory bodies.
Contact with us
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Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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